Compositions for treating hypercholesterolemia

ABSTRACT

Anti-anal leakage agents are used in combination with liquid polyol fatty acid polyesters to provide pharmaceutical and food compositions for treating and/or preventing hypercholesterolemia while avoiding undesired anal leakage of the liquid polyesters.

BACKGROUND OF THE INVENTION

The present invention relates to certain edible, but non-absorbable andnon-digestible, liquid polyesters which can be used as low calorie fatsubstitutes in foods and as pharmaceutical compositions. The polyestersherein interfere with the body's absorption of cholesterol and therebyprovide a means for treating hypercholesterolemia. It has now beendetermined that the liquid polyesters herein can also cause an undesiredanal leakage effect. By the present invention, certain agents are addedto the polyester compositions to avoid this undesired effect. Highlypreferred compositions for treating hypercholesterolemia and/orhyperlipidemia comprising the polyesters and anti-anal leakage agent areprovided.

High blood cholesterol (hypercholesterolemia) is recognized as being arisk factor in cardiovascular disease which comprises a major healthcare problem today. Epidemiological studies have demonstrated that, withfew exceptions, populations consuming large quantities of saturated fatand cholesterol have a relatively high concentration of serumcholesterol and a high mortality rate from coronary heart disease. Whileit is recognized that other factors can also contribute to thedevelopment of cardiovascular disease, there appears to be a causalrelationship between the concentration of serum cholesterol, in whichhypercholesterolemia results in the accumulation of undesirable amountsof cholesterol in various parts of the circulatory system(atherosclerosis) or in soft tissues (xanthomatosis), and coronarydisease and coronary mortality rates.

A variety of dietary and drug regimens have been suggested foralleviating or preventing hypercholesterolemia.

By providing a fat substitute which is non-absorbable andnon-digestible, the total content of cholesterol in the body can belowered. Mineral oil is a well-known laxative and has been suggested foruse as a fat substitute and as a kind of "intestinal solvent" todissolve cholesterol and cause its removal in body wastes. However,mineral oil has never been accepted for these uses. Moreover, mineraloil is partially absorbed by the body and undesirably deposits in theliver.

In the present invention, liquid, non-absorbable, non-digestiblepolyesters of sugars (or sugar alcohols) are used as fat substitutes infoods and, conveniently, in unit dose forms as therapeutic compositions.The polyesters herein are fat-like in their physical properties and areexcellent fat substitutes for use in low calorie foods and diets.Moreover, the polyesters herein efficiently inhibit absorption ofcholesterol by the body and, in contrast with mineral oil, are notabsorbed and/or deposited in the liver during usage in atreatment/prevention regimen with persons having or likely to develophypercholesterolemia.

The anal leakage effect of the liquid polyesters of the type disclosedherein can be overcome by adding an anti-anal leakage agent of the typedisclosed hereinafter to the liquid polyesters, or to foods containingsame.

The following references are relevant to the present invention.

The copending application of Mattson, Ser. No. 628,265, filed Nov. 3,1975, entitled COMPOSITIONS FOR INHIBITING ABSORPTION OF CHOLESTEROL,discloses vitamin-fortified liquid and solid polyesters of the generaltype employed herein, their use as anti-hypercholesterolemic andanti-hyperlipidemic agents, and their stool-softening laxative effect.

The concurrently-filed application of Jandacek and Mattson, Ser. No.657,529, filed Feb. 12, 1976, P&G Attorney's Docket No. 2309, entitledVITAMINIZED COMPOSITIONS FOR TREATING HYPERCHOLESTEROLEMIA, disclosesternary compositions comprising fat-soluble vitamins, anti-anal leakageagents and a liquid polyester of the type employed herein.

U.S. Pat. No. 3,600,186 (1971) to Mattson and Volpenhein discloses lowcalorie food compositions containing polyol polyesters of the generaltype employed herein, and their use in combination with hardstocks whichare fatty acid sources. The anti-anal leakage effect of fatty acids isnot noted.

The copending application of Mattson and Volpenhein, entitledPHARMACEUTICAL COMPOSITIONS FOR INHIBITING ABSORPTION OF CHOLESTEROL,Ser. No. 425,010, filed Dec. 14, 1973, now U.S. Pat. No. 3,954,976discloses and claims sugar polyesters of the general type employedherein for the treatment and/or prevention of hypercholesterolemia. Avariety of optional carriers are mentioned, including the fatty acid,stearic acid. The anti-anal leakage effect of stearic acid is notmentioned.

U.S. Pat. No. 1,656,474 (1928) to Dubin discloses edible fatcompositions consisting of ethyl and glycerol esters of odd chain fattyacids in combination with fat-soluble vitamins.

Mattson and Nolen, The Journal of Nutrition Vol. 102, No. 9, September1972, at pages 1171-1175, report on the lack of absorbability of sugarpolyesters of the general type employed herein in rats.

Fallet, Glueck, Mattson and Lutmer, Clinical Research XXIII No. 3, page319A (1975) report the lowering of both serum cholesterol and vitamin Aand E levels in subjects receiving sugar polyesters of the present type.

U.S. Pat. No. 2,962,419 (1960) to Minich relates to neopentyl fattyesters and their use as fat substitutes.

U.S. Pat. No. 3,160,565 (1964) to H. E. Duell relates to sugar mono-,di- and tri-esters and their use as carriers for varyingorally-administered medicinals.

U.S. Pat. No. 3,849,554 (1974) to Winitz discloses means for reducingblood serum cholesterol by injesting diets comprising a fatty acidsource, said diets being low in sucrose.

U.S. Pat. No. 2,893,990 (1959) to Hass, et al., discloses fatty acidmono- and di-esters of sucrose which aid in the absorption of fat fromthe digestive tract.

U.S. Pat. No. 3,158,490 (1964) to Baur and Lutton discloses non-cloudysalad oils containing esters of disaccharides in which there are notmore than five un-esterified hydroxy groups. See also U.S. Pat. Nos.3,059,009 (1962) and 3,059,010 (1962) to Schmid and Baur.

U.S. Pat. No. 2,997,492 (1961) to Martin is directed to a method ofmaking partial fatty acid esters of hexitols. U.S. Pat. No. 2,997,491(1961) to Huber is directed to the synthesis of partial fatty esters ofinositol. The general methods of synthesis disclosed in these patentscan be used to prepare the liquid polyesters herein. Preferred methodsof synthesis are fully disclosed hereinafter.

SUMMARY OF THE INVENTION

Administration of anti-hypercholesterolemic amounts of a compositioncomprising a liquid polyester of the type described herein to an animal(especially humans) afflicted with or susceptible tohypercholesterolemia is an effective means of controlling the body'scholesterol level. Unfortunately, administration ofcholesterol-controlling amounts of the liquid polyesters can result inan undesired "laxative" effect, namely, leakage of the liquid polyesterthrough the anal sphincter. By combining the polyester compositions withan anti-laxative agent, especially a C₁₂, or higher, saturated fattyacid, or edible source which provides such fatty acids in the gut, thisundesired laxative effect is prevented. (By "anti-anal leakage agent",or "AAL" agent, herein is meant those materials which prevent frankleakage of the liquid polyesters. The natural stool-softening effect ofthe polyesters is not substantially affected, nor is it a problem.)

The present invention encompasses compositions of matter which comprisea liquid, non-absorbable, nondigestible polyol fatty acid polyester ofthe type described hereinafter, and an anti-laxative, or "stiffening",amount of an anti-laxative agent, especially sources of C₁₂, or higher,fatty acids. The compositions can be used as fat substitutes in cookingor can be self-administered to reduce the body's cholesterol level. Suchcompositions also find use as diet aids for the hyperlipidemicindividual.

The present invention also encompasses non-laxative pharmaceuticalcompositions in effective unit dosage amounts for inhibiting theabsorption of cholesterol, said compositions comprising from about 1gram to about 5 grams of the liquid polyesters herein and sufficient AALagent, especially a C₁₂, or higher, saturated fatty acid, or ediblesource thereof, to prevent anal leakage in humans ingesting saidcompositions.

The polyester materials herein are non-absorbable and non-digestiblefat-like materials and are suitable for use as fat substitutes in lowcalorie fat-containing food compositions. Accordingly, the presentinvention also encompasses low calorie fat-containing food compositionscomprising non-fat ingredients and fat ingredients wherein from about10% to about 100% of the total fat ingredients comprise the liquid,non-absorbable, non-digestible polyesters of the type disclosedhereinafter, said compositions also containing an effective amount of anAAL agent, especially a C₁₂, or higher, saturated fatty acid, or anedible source of fatty acids, which prevents an undesired anal leakageeffect.

The present invention also encompasses methods for inhibiting theabsorption of cholesterol without causing an anal leakage effect,comprising systemically (generally, orally) administering to animalssusceptible to or afflicted with hypercholesterolemia successivetherapeutically effective doses of the compositions of the foregoingtype.

It is to be understood that the edible, non-absorbable, non-digestiblepolyester materials herein are liquids at body temperature, i.e., have amelting point of ca. 37° C. or below. (Edible, non-absorbable,non-digestible polyester materials that are solid at body temperature donot exhibit the undesirable anal leakage effects noted with the liquidpolyesters. Indeed, such solid polyesters can be used as one type of AALagent herein.) In general, the liquid polyesters are those which aremade from unsaturated fatty acids, whereas the solid polyesters aresubstantially saturated.

DETAILED DESCRIPTION OF THE INVENTION

The consumption of diets containing sucrose polyesters (SPE) has beenshown to result in the desirable decrease in absorption of dietarycholesterol in animals; see Mattson, Mandacek and Glucek, ClinicalResearch 23 445A (1975). Similar results have been noted in humans.

In studies of the foregoing type, rats which ingested about 300 mg. toabout 3000 mg. total liquid polyester per day and human volunteers whoingested from about 10 grams to about 50 grams total liquid polyesterper day exhibited undesired anal leakage of the polyesters. Furtherstudies indicated that this anal leakage effect was a direct result ofthe passage of the polyesters through the anal sphincter. Briefly, thisundesired effect is not unlike the effect which can be caused by theingestion of excessive amounts of mineral oil. It has now beendetermined that this undesirable effect can be obviated by combining theliquid polyester compositions with certain AAL agents.

The types of AAL agents which can be used herein to overcome theabove-described anal leakage problem without interfering with thebeneficial effects of the present compositions are disclosed immediatelyhereinafter.

Anti-Anal Leakage Agents

One class of materials which provide the anti-anal leakage effect hereinincludes fatty acids having a melting point of ca. 37° C., or higher,and ingestible, digestible sources of such fatty acids. The fatty acidAAL agents include, for example, the C₁₂ -C₂₄ saturated fatty acids, andingestible, digestible sources thereof.

While not intending to be limited by theory, it appears that theforegoing type of AAL agent functions via the formation of calcium ormagnesium fatty acid soaps in the gut. These soaps apparently interactwith the liquid polyesters herein and impart a "stiffening" effectthereto. Once "stiffened", or partly solidified, in the gut, thepolyesters do not leak through the anal sphincter. Theantihypercholesterolemic effect of the liquid polyesters is notdiminished.

Non-limiting examples of saturated fatty acids and sources thereof whichcan be used as the AAL agent herein include the free saturated fattyacids per se, compounds such as esters (e.g., triglycerides) that yieldsuch saturated fatty acids on hydrolysis in the gut, soaps of the fattyacids such as the sodium, potassium, etc., water-soluble soaps, as wellas the calcium and magnesium water-insoluble soaps.

Highly preferred herein for their anti-anal leakage effect are the C₁₆-C₂₂, most preferably C₁₆ -C₁₈, saturated fatty acids, or edible sourcesthereof.

Specific examples of materials useful as the foregoing type of AAL agentherein include natural or processed fats yielding C₁₂ -C₂₄ saturatedfatty acids in the gut, e.g., materials such as cocoa butter, palm oil,palm kernel oil, coconut oil, tallow, lard, enriched concentrates oftriglycerides having high levels of saturated fatty acids obtainablefrom these sources and sources such as highly saturated cottonseed oilfractions obtained by processes such as crystallization or directedrearrangement which yield the desired higher concentrations of the moresaturated fatty acids in the resulting "hardstock" fractions. Suchmaterials are all available by well-known processes.

Partially hydrogenated oils, including all of the above, as well aspartially hydrogenated soybean oil, safflower seed oil, rapeseed oil, orsuch materials which are hydrogenated and concentrated, for example bycrystallization, to provide fractions which are enriched in sources ofthe longer-chain, substantially saturated fatty acids, are all useful asthe AAL agent herein. (By "substantially hydrogenated" herein is meantoils having an iodine value of ca. 50, or lower.)

Of course, any of the foregoing unsaturated oils are useful herein afterthey have been substantially completely hydrogenated to convert theunsaturated fatty acid (ester) groups to the corresponding saturatedfatty acids.

Synthetic materials, especially fatty acid esters made from the C₁₂-C₂₄, more preferably C₁₆ -C₂₂, most preferably C₁₆ -C₁₈, saturatedfatty acids are useful herein. Such materials include the esters oftetrahydric alcohols such as erythritol, esters of pentahydric alcoholssuch as xylitol, and esters of hexahydric alcohols such as sorbitol, andthe like.

The C₁₂ -C₂₄ saturated fatty acid esters of monohydric alcohols such asmethyl, ethyl and propyl alcohols (preferably ethyl alcohol) are alsouseful herein. Esters of dihydric alcohols such as 1,2-propanediol,1,3-butanediol, and the like, can also be used.

Highly preferred AAL agents herein which yield the foregoing fatty acidson hydrolysis in the gut are those which, in combination with the liquidpolyesters herein, provide compositions having aesthetically pleasingorganoleptic qualities, i.e., better "mouth feel". Such aestheticallypleasing materials include naturally occurring cocoa butter and varioussynthetic cocoa and confectioners' butters. These preferred AAL agentsinclude, for example, the so-called "position-specific" triglyceridessuch as 1-stearoyl diolein (SOO); 2-oleoyl-1,3-distearin (SOS); or thecorresponding compounds wherein the stearoyl group is replaced bypalmitoyl, arachidoyl or behenoyl groups. Another class of aestheticallypreferred anti-laxative agents herein are 1-oleoyl distearin (OSS),1-palmitoyl distearin (PSS), 1-arachidoyl distearin (ASS) and 1-behenoyldistearin (BSS).

These highly preferred, position-specific triglycerides which can beused as a fatty acid source-type of AAL agent herein can be preparedaccording to the methods described in U.S. Pat. No. 3,809,711, Yetter,issued May 7, 1974, the disclosures of which are incorporated herein byreference.

As noted hereinabove, the foregoing types of AAL agents appear tofunction by providing a saturated fatty acid in the gut, said fatty acidthereafter presumably forming an insoluble calcium or magnesium soap insitu. This soap then appears to provide the "stiffening" effect on theliquid polyester, thereby preventing the undesirable anal leakageeffect. As noted hereinabove, the solid polyester materials of thepresent type (i.e., solid, edible, but non-digestible, non-absorbablepolyesters) do not cause the undesirable anal leakage effect. It hasbeen determined that these solid polyester materials can also be used asan AAL agent and these represent a second class of AAL agents herein.Since these solid polyester materials do not hydrolyze in the gut toform free fatty acids, or calcium or magnesium fatty acid soaps, theiranti-anal leakage effect must be the result of a different mechanismfrom that which operates with the hydrolyzable esters and fatty acidsources described immediately hereinabove. Presumably, the combinationof the solid polyester with the liquid polyesters simply provides astiffening effect due to some type of crystallization or phase changewithin the gut.

It will be appreciated that by combining liquid and solidnon-absorbable, non-digestible polyesters to provide the desiredanti-anal leakage effect, wholly edible, but non-digestible,non-absorbable, non-caloric compositions are secured. These compositionsare quite effective in the treatment of hypercholesterolemia and in lowcalorie diets.

Typical examples of solid, non-absorbable, non-digestible polyester AALagents herein include sucrose octastearate, sucrose octapalmitate,sucrose heptastearate, xylitol pentastearate, galactose pentapalmitate,and like, saturated polyol polyesters having at least four --OH groupsesterified with C₁₀ -C₂₂ saturated fatty acids.

Another type of AAL agent herein comprises fatty acid esters which arenon-digestible by virtue of branching on the α-carbon atom of the fattyacid moiety. Such materials, which are well known in the chemical arts,include, for example, α-methyl and α,α-dimethyl C₁₀ -C₁₈ fatty acidesters of lower alcohols such as ethanol and of polyols such asglycerol.

LIQUID POLYESTERS

The liquid polyol polyesters (or simply, polyesters) employed in thisinvention comprise certain polyols, especially sugars or sugar alcohols,esterified with at least four fatty acid groups. Accordingly, the polyolstarting material must have at least four esterifiable hydroxyl groups.Examples of preferred polyols are sugars, including monosaccharides anddisaccharides, and sugar alcohols. Examples of monosaccharidescontaining four hydroxyl groups are xylose and arabinose and the sugaralcohol derived from xylose, which has five hydroxyl groups, i.e.,xylitol. (The monosaccharide, erythrose, is not suitable in the practiceof this invention since it only contains three hydroxyl groups, but thesugar alcohol derived from erythrose, i.e., erythritol, contains fourhydroxyl groups and accordingly can be used.) Suitable five hydroxylgroup-containing monosaccharides are galactose, fructose, and sorbose.Sugar alcohols containing six --OH groups derived from the hydrolysisproducts of sucrose, as well as glucose and sorbose, e.g., sorbitol, arealso suitable. Examples of disaccharide polyols which can be usedinclude maltose, lactose, and sucrose, all of which contain eighthydroxyl groups.

Preferred polyols for preparing the polyesters for use in the presentinvention are selected from the group consisting of erythritol, xylitol,sorbitol, glucose and sucrose. Sucrose is especially preferred.

The polyol starting material having at least four hydroxyl groups mustbe esterified on at least four of the --OH groups with a fatty acidcontaining from about 8 to about 22 carbon atoms. Examples of such fattyacids include caprylic, capric, lauric, myristic, myristoleic, palmitic,palmitoleic, stearic, oleic, ricinoleic, linoleic, linolenic,eleostearic, arachidic, arachidonic, behenic, and erucic acid. The fattyacids can be derived from naturally occurring or synthetic fatty acids;they can be saturated or unsaturated, including positional andgeometrical isomers. However, in order to provide liquid polyesters ofthe type used herein, at least about half of the fatty acid incorporatedinto the polyester molecule must be unsaturated. Oleic and linoleicacids, and mixtures thereof, are especially preferred.

The liquid polyol fatty acid polyesters useful in this invention mustcontain at least four fatty acid ester groups. Polyol fatty acidpolyester compounds that contain three or less fatty acid ester groupsare digested in and the products of digestion are absorbed from theintestinal tract much in the manner of ordinary triglyceride fats,whereas the polyol fatty acid polyester compounds that contain four ormore fatty acid ester groups are substantially non-digestible andconsequently non-absorbable by the human body. It is not necessary thatall of the hydroxyl groups of the polyol be esterified with fatty acid,but it is preferable that the polyester contain no more than twounesterified hydroxyl groups. Most preferably, substantially all of thehydroxyl groups of the polyol are esterified with fatty acid, i.e., thecompound is substantially completely esterified. The fatty acidsesterified to the polyol molecule can be the same or mixed (but, asnoted above, a substantial amount of the unsaturated acid ester groupsmust be present to provide liquidity).

To illustrate the above points, a sucrose fatty triester would not besuitable for use herein because it does not contain the required fourfatty acid ester groups. A sucrose tetra-fatty acid ester would besuitable, but is not preferred because it has more than two unesterifiedhydroxyl groups. A sucrose hexa-fatty acid ester would be preferredbecause it has no more than two unesterified hydroxyl groups. Highlypreferred compounds in which all the hydroxyl groups are esterified withfatty acid include the liquid sucrose octa-fatty acid esters.

The following are non-limiting examples of specific liquid polyol fattyacid polyesters containing at least four fatty acid ester groupssuitable for use in the present invention: glucose tetraoleate, theglucose tetraesters of soybean oil fatty acids (unsaturated), themannose tetraesters of mixed soybean oil fatty acids, the galactosetetraesters of oleic acid, the arabinose tetraesters of linoleic acid,xylose tetralinoleate, galactose pentaoleate, sorbitol tetraoleate, thesorbitol hexaesters of unsaturated soybean oil fatty acids, xylitolpentaoleate, sucrose tetraoleate, sucrose pentaoleate, sucrosehexaoleate, sucrose heptaoleate, sucrose octaoleate, and mixturesthereof.

As noted above, highly preferred polyol fatty acid esters are thosewherein the fatty acids contain from about 14 to about 18 carbon atoms.

The polyol fatty acid polyesters suitable for use herein can be preparedby a variety of methods well known to those skilled in the art. Thesemethods include: transesterification of the polyol with methyl, ethyl orglycerol fatty acid esters using a variety of catalysts; acylation ofthe polyol with a fatty acid chloride; acylation of the polyol with afatty acid anhydride; and acylation of the polyol with a fatty acid, perse. As an example, the preparation of polyol fatty acid esters isdescribed in U.S. Pat. No. 2,831,854, incorporated herein by reference.

Specific, but non-limiting, examples of the preparation of polyol fattyacid esters suitable for use in the practice of this invention are asfollows.

Erythritol tetraoleate -- Erythritol and a five-fold molar excess ofmethyl oleate are heated at 180° C., under vacuum, with agitation, inthe presence of sodium methoxide catalyst over two reaction periods ofseveral hours each. The reaction product (predominately erythritoltetraoleate) is refined in petroleum ether and crystallized three timesfrom several volumes of acetne at 1° C. acetone

Xylitol pentaoleate -- Xylitol and a five-fold molar excess of methyloleate in dimethylacetamide (DMAC) solution are heated at 180° C. forfive hours in the presence of sodium methoxide catalyst, under vacuum.During this time the DMAC is removed by distillation. The product(predominately xylitol pentaoleate) is refined in petroleum ethersolution and, after being freed of petroleum ether, is separated as aliquid layer four times from acetone at ca. 1° C. and twice from alcoholat ca. 10° C.

Sorbitol hexaoleate is prepared by essentially the same procedure usedto prepare xylitol pentaoleate except that sorbitol is substituted forxylitol.

Sucrose octaoleate is prepared by substantially the same procedure asthat used to prepare erythritol tetraoleate except that sucrose issubstituted for erythritol.

In therapeutic regimens the dosage of the compositions herein can varywith the severity of the hypercholesterolemic condition and the durationof the treatment. Individual dosages can range from about 0.01 mg./kg.to about 500 mg./kg., and greater (unless otherwise specified, the unitdesignated "mg./kg." as used herein refers to mg. of liquid polyesterper kilogram of body weight), preferably from about 0.1 mg./kg. to about125 mg./kg. per dosage, with up to six dosages, preferably threedosages, being given daily, most preferably at meal times. Because ofthe AAL agent, such high dosages can be administered without fear ofproducing anal leakage effects. Dosages of less than about 0.1 mg./kg.do not materially inhibit the absorption of cholesterol in mostpatients. The dosages can be administered orally in any suitable unitdosage form such as pills, tablets, and capsules. Preferred are capsulesmade from gelatin. The dosages can also be administered as part of acontrolled dietary regimen, e.g., as a synthetic salad oil or cookingoil or fat.

The pharmaceutical compositions herein can comprise the polyester/AALagent alone, or in combination with any desired, non-interferingpharmaceutical carrier. As used herein, the term "pharmaceuticalcarrier" means a solid or liquid filler, diluent or encapsulatingsubstance. Some examples of the substances which can serve aspharmaceutical carriers are sugars such as lactose, glucose and sucrose;starches such as corn starch and potato starch; cellulose and itsderivatives such as sodium carboxymethylcellulose, ethylcellulose,cellulose acetate; powdered tragacanth; malt; gelatin; talc; oils suchas peanut oil, cottonseed oil, sesame oil, olive oil, corn oil andsoybean oil; polyols such as propylene glycol, glycerin, sorbitol,mannitol, and polyethylene glycol; agar; alginic acid; pyrogen-freewater; isotonic saline; ethyl alcohol and phosphate buffer solutions, aswell as other non-toxic compatible substances used in pharmaceuticalformulations. Wetting agents and lubricants such as sodium laurylsulfate, as well as coloring agents, flavoring agents and preservativescan also be present in the compositions, according to the desires of theformulator.

The pharmaceutical carriers of the foregoing type can optionally beemployed in conjunction with the liquid polyesters herein to provide apractical size to dosage relationship, composition forms which can beeasily ingested, and means for providing accurate unit dosages in aconvenient form. The pharmaceutical carrier usually will comprise fromabout 5% to about 50% by weight of the total pharmaceutical composition.

Since the liquid polyesters of the present compositions are not unlikecooking and salad oils and fats in their physical properties, thepresent compositions can be used as a partial or total replacement fornormal triglyceride fats in any fat-containing food composition toprovide anti-hypercholesterolemic and low calorie benefits. In order toachieve these benefits in a reasonable time, it is necessary that atleast about 10% of the fat in the food composition comprises thepolyesters herein. Highly desirable food compositions are those whereinthe fatty component comprises up to about 100% of thepolyester/anti-anal leakage compositions herein. Accordingly, thecompositions of this invention can be used as a partial or completereplacement for normal triglyceride fats in a salad or cooking oil, orin plastic shortenings for use in frying, cake making, bread making, andthe like. The compositions can also be used as partial or completereplacements for normal triglyceride fats in fat-containing foodproducts such as mayonnaise, margarine, and dairy products.

Preferred fat-containing food compositions of the present type comprisenon-fat ingredients and fat ingredients wherein from about 10% to about95% of the total fat consists essentially of a liquid sugar fatty acidpolyester having at least four fatty acid ester groups, each fatty acidhaving from about 8 to about 22 carbon atoms, said sugar fatty acidpolyester and/or food composition made therefrom also comprising an AALagent of the type disclosed herein. Such food compositions will mostoften contain at least about 10%, generally 15% to 25% (by weight ofliquid polyester) of a fatty acid source which provides the anti-analleakage effect. Highly preferred are food compositions wherein the sugarfatty acid ester contains no more than two unesterified hydroxyl groups.Liquid sucrose polyesters, especially those wherein the ester groups aremainly of the unsaturated type and contain 14 to 18 carbon atoms, whenused in the manner of this invention, are especially preferred for usein such anti-hypercholesterolemic and low calorie food compositions.

The total AAL agent employed in any of the compositions and methodsherein will depend somewhat on the total amount of liquid polyesterbeing ingested per day. The anti-anal leakage agent should be present inan amount equaling at least about 10% by weight of the liquid polyester.It is more preferred that the AAL agent comprises at least about 20% byweight of the liquid polyester to ensure that anal leakage does not,even at high ingestion rates. Compositions wherein the weight of AALagent comprises from about 20% to about 50% of the weight of liquidpolyester provide excellent control of serum cholesterol without analleakage of the polyester.

Compositions comprising edible fatty acids, their edible salts or theiredible, digestible esters as the AAL agent preferably comprise about 10%to about 50% by weight of these materials by weight of liquid polyester.Compositions using the palatable position-specific triglycerides as theAAL agent preferably comprise about 20% to about 40% (by weight ofliquid polyester) of these AAL agents. When the edible, non-absorbable,non-digestible solid polyesters are used as the AAL agent, they arepreferably used at a rate of from about 20% to about 50% by weight ofthe liquid polyester.

The following, non-limiting examples illustrate the compositions andprocesses of this invention. It will be appreciated that sugars andsugar alcohols, appropriately esterified, are encompassed by the term"sugar" as used herein and such materials can be interchanged in thecompositions.

EXAMPLE I

Gelatin capsules for use by the hypercholesterolemic patient areprepared by conventional methods, as follows:

    ______________________________________                                        Ingredient     Amount per Capsule                                             ______________________________________                                        Sucrose polyester*                                                                           2000 mg.                                                       Stearic Acid    250 mg.                                                       ______________________________________                                         *Liquid mixed hexa, hepta and octasucrose esters, predominately the           octaester, esterified with mixed soybean oil fatty acids, predominately i     the C.sub.16 -C.sub.18  chain length.                                    

The capsules of the foregoing type are prepared by simply mixing theingredients and filling the standard gelatin capsules. The capsules areadministered orally three times daily (three with each meal). Thistreatment regimen inhibits cholesterol uptake significantly anddecreases the serum cholesterol levels in the circulatory systems ofhumans with, or disposed towards, hypercholesterolemia. The patients arenot troubled by undesired anal leakage with this regimen.

Similar results are obtained when the sucrose polyester in the capsulesof Example I is replaced with an equivalent quantity of a fatty acidpolyester selected from the group consisting of glucose tetraoleate;glucose tetraoleate; mixed glucose tetraesters of unsaturated soybeanoil fatty acids; mixed mannose tetraesters of oleic acid; mixedgalactose tetraesters of linoleic acid; mixed arabinose tetraesters ofoleic acid; xylose tetralinoleate; galactose pentaoleate; sorbitoltetraoleate; sucrose tetraoleate; sucrose pentaoleate; sucrosehexaoleate; sucrose heptaoleate; and sucrose octaoleate, respectively.

In the composition of Example I, the stearic acid anti-anal leakageingredient is replaced by an equivalent amount of methyl stearate,propyl stearate, methyl behenate, ethyl behenate, substantiallycompletely hydrogenated palm oil, hydrogenated rapeseed oil, and mixedhydrogenated tallow triglycerides, respectively, and equivalent resultsare secured.

Preferred pharmaceutical compositions of the type of Example I forinhibiting the absorption of cholesterol, especially in the human body,preferably comprise from about 0.1 gram to about 5 grams of the liquidpolyester and an effective amount (as disclosed hereinabove) of the AALagent.

EXAMPLE II

Gelatin capsules comprising a unit dose of an AAL agent and a liquidpolyester are prepared by conventional means, as follows:

    ______________________________________                                        Ingredient       Amount per Capsule                                           ______________________________________                                        Sucrose octaoleate                                                                             3500 mg.                                                     Hydrogenated palm oil                                                                           750 mg.                                                     ______________________________________                                    

The above capsules are administered orally three times daily (three permeal/70 kg. man) over a one-month period. This treatment regimensubstantially inhibits cholesterol uptake in the patient and decreasesthe serum level of cholesterol. No anal leakage from use of the capsulesis noted.

The hydrogenated palm oil in Example II is replaced by an equivalentamount of tristearin and equivalent anti-anal leakage results aresecured.

When oleic acid is used to replace the hydrogenated palm oil, nosubstantial anti-anal leakage effect is noted.

EXAMPLE III

Gelatin capsules comprising an AAL agent and a liquid polyester are asfollows:

    ______________________________________                                        Ingredient      Mg. per Capsule                                               ______________________________________                                        Sucrose octaoleate                                                                            2000                                                          Ethyl stearate   250                                                          ______________________________________                                    

Three capsules of the type prepared in Example III are administeredorally five times daily (three capsules per occurrence) to inhibitcholesterol uptake and decrease the level of cholesterol in thecirculatory system of a 70 kg. patient afflicted withhypercholesterolemia. At these dosage levels, no anal leakage is noted.Similar dosages of the foregoing capsules without ethyl stearate causean undesired leakage of sucrose octaoleate through the anal sphincter.

EXAMPLE IV

A highly palatable, low calorie composition suitable for use by patientson anti-hypercholesterolemic therapeutic regimens and/or as a cookingfat substitute by individuals on an anti-hyperlipidemic diet is asfollows:

    ______________________________________                                        Ingredient         % by Weight                                                ______________________________________                                        Liquid sucrose polyester*                                                                        50                                                         Cocoa butter       50                                                         ______________________________________                                         *Avg. 7.5 ester of sucrose and oleic acid.                               

The composition of the foregoing type is suitable for use in standardfashion as a low calorie cooking fat. No anal leakage of the liquidpolyester is noted.

The composition of Example IV is ingested at a rate of 50 g./day (150lb. patient) and reduces serum cholesterol without anal leakage of theliquid polyester.

In the composition of Example IV the natural cocoa butter is replaced byan equivalent amount of the position-specific triglycerides SOO, SOS,OSS, PSS, ASS and BSS, respectively, and equivalent compositions aresecured.

EXAMPLE V

A plastic shortening is prepared from the following ingredients.

    ______________________________________                                        Ingredient         % by Weight                                                ______________________________________                                        Cocoa butter       40                                                         Liquid xylitol pentaoleate                                                                       50                                                         OSS                10                                                         ______________________________________                                    

The composition of Example V is prepared by thoroughly mixing theindicated ingredients. The composition is suitable for use in frying andother types of cooking where a plastic fat is employed. The fatcomposition of Example V can also be employed in the preparation ofbaking doughs suitable for use by the hypercholesterolemic patient.Continued ingestion of the plastic shortening of Example V, or foodsmade therefrom, reduces the body's serum cholesterol level without analleakage of the xylitol pentaoleate.

The shortening of Example V can be used by the normal or hyperlipidemicpatient to control body weight.

EXAMPLE VI

A non-anal leakage, low calorie, anti-hypercholesterolemic compositionprepared with an edible, but non-absorbable, non-digestible, solidpolyester AAL agent is as follows:

    ______________________________________                                        Ingredient       % by Weight                                                  ______________________________________                                        Sucrose octaoleate                                                                             70                                                           Sucrose octastearate                                                                           30                                                           ______________________________________                                    

The composition of Example VI is prepared by simply combining theingredients. The composition is suitable for use by thehypercholesterolemic patient to reduce serum cholesterol levels; no analleakage is noted.

The composition of Example VI can be used by the normal orhyperlipidemic patient to control serum cholesterol without increasingcaloric intake.

In the composition of Example VI the sucrose octastearate is replaced byan equivalent amount of sucrose heptastearate, and sucroseoctapalmitate, respectively, as the AAL agent and equivalent results aresecured.

What is claimed is:
 1. A composition of matter, comprising:(a) anedible, non-absorbable, non-digestible liquid polyol fatty acidpolyester having at least 4 fatty acid ester groups, wherein the polyolis selected from the group consisting of sugars and sugar alcoholscontaining from 4 to 8 hydroxyl groups and wherein each fatty acid grouphas from about 8 to about 22 carbon atoms; and (b) sufficient anti-analleakage agent to prevent leakage of said liquid polyester through theanal sphincter.Iadd., wherein the anti-anal leakage agent is a memberselected from the group consisting of: edible C₁₂ and higher saturatedfatty acids, and their edible salts; edible, digestible sources of C₁₂and higher saturated fatty acids, other than tristearin or C₁₈ saturatedfatty acid esters of 1,3-propanediol; edible, non-absorbable,non-digestible solid polyol fatty acid polyesters having at least 4fatty acid ester groups, wherein the polyol is selected from the groupconsisting of sugars and sugar alcohols containing from 4 to 8 hydroxylgroups and wherein each fatty acid group is a saturated fatty acid grouphaving from about 8 to about 22 carbon atoms; and edible, non-digestibleesters of alpha-branched chain C₁₀ -C₁₈ fatty acids.Iaddend..
 2. Acomposition according to claim 1 wherein the liquid polyol fatty acidpolyester contains no more than about 2 free hydroxyl groups.
 3. Acomposition according to claim 2 wherein the fatty acid ester groupscontain from about 14 to about 18 carbon atoms.
 4. A compositionaccording to claim 3 wherein the polyol is a member selected from thegroup consisting of erythritol, xylitol, sorbitol, glucose and sucrose..[.
 5. A composition according to claim 4 wherein the polyol issucrose..]. .[.6. A composition according to claim 5 wherein the sucrosefatty acid polyester is a member selected from the group consisting ofthe hexaoleate, heptaoleate and octaoleate of sucrose, and mixturesthereof..]. .[.7. A composition according to claim 1 wherein theanti-anal leakage agent is a member selected from the group consistingof: edible C₁₂ and higher saturated fatty acids, and their edible salts;edible, digestible sources of C₁₂ and higher saturated fatty acids;edible, non-absorbable, non-digestible solid polyol fatty acidpolyesters having at least 4 fatty acid ester groups, wherein the polyolis selected from the group consisting of sugars and sugar alcoholscontaining from 4 to 8 hydroxyl groups and wherein each fatty acid grouphas from about 8 to about 22 carbon atoms; and edible, non-digestibleesters of alpha-branched chain C₁₀ -C₁₈ fatty acids..].
 8. A compositionaccording to claim .[.7.]. .Iadd.1 .Iaddend.which comprises at leastabout 10% by weight of the anti-anal leakage agent.
 9. A compositionaccording to claim .[.7.]. .Iadd.1 .Iaddend.which comprises at leastabout 20% by weight of the anti-anal leakage agent.
 10. A compositionaccording to claim .[.7.]. .Iadd.1 .Iaddend.which comprises from about20% to about 50% by weight of the anti-anal leakage agent.
 11. Acomposition according to claim .[.7.]. .Iadd.1 .Iaddend.which comprisesfrom about 10% to about 50% by weight of an anti-anal leakage agentselected from the group consisting of edible C₁₂ -C₂₄ saturated fattyacids and edible salts of C₁₂ -C₂₄ saturated fatty acids.
 12. Acomposition according to claim .[.7.]. .Iadd.1 .Iaddend.which comprisesfrom about 10% to about 50% by weight of an anti-anal leakage agentselected from the group consisting of edible, digestible sources of C₁₂-C₂₄ saturated fatty acids, and mixtures thereof.Iadd., other thantristearin or C₁₈ saturated fatty acid esters of1,3-propanediol.Iaddend..
 13. A composition according to claim 12wherein the anti-anal leakage agent is a lower alkyl ester of C₁₂ -C₂₄saturated fatty acids, or mixtures thereof.
 14. A composition accordingto claim 12 wherein the anti-anal leakage agent comprises substantiallysaturated triglyceride esters of C₁₂ -C₂₄ fatty acids, or mixturesthereof.Iadd., other than tristearin.Iaddend..
 15. A compositionaccording to claim 14 wherein the anti-anal leakage agent ishydrogenated palm oil.
 16. A composition according to claim 14 whereinthe anti-anal leakage agent is natural or synthetic cocoa butter.
 17. Acomposition according to claim 14 wherein the anti-anal leakage agent isan edible position-specific triglyceride selected from the groupconsisting of: the 1-stearoyl, 1-palmitoyl, 1-arachidoyl and 1-behenoyl2,3-dioleins; the 2-oleoyl 1,3-distearins, 1,3-dipalmitins,1,3-diarachidins and 1,3-dibehenins; 1-oleoyl distearin; 1-palmitoyldistearin; 1-arachidoyl distearin; and 1-behenoyl distearin; andmixtures thereof.
 18. A composition according to claim 17 whichcomprises from about 20% to about 40% by weight of the position-specifictriglyceride.
 19. A composition according to claim .[.7.]. .Iadd.1.Iaddend.which comprises from about 20% to about 50% by weight of ananti-anal leakage agent selected from the group consisting of edible,non-absorbable, non-digestible solid polyol fatty acid polyesters havingat least 4 fatty acid ester groups, wherein the polyol is selected fromthe group consisting of sugars and sugar alcohols containing from 4 to 8hydroxyl groups and wherein each fatty acid group .[.has.]. .Iadd.is asaturated fatty acid group having .Iaddend.from about .[.8.]. .Iadd.10.Iaddend.to about 22 carbon atoms.
 20. A composition according to claim19 wherein the anti-anal leakage agent is selected from the groupconsisting of .[.C₁₀ -C₂₂ saturated fatty acid polyol esters.]..Iadd.sucrose octastearate, sucrose octapalmitate, sucroseheptastearate, xylitol pentastearate and galactosepentapalmitate.Iaddend..
 21. A method for inhibiting the absorption ofcholesterol in animals without causing an anal leakage effect comprisingsystemically administering to an animal susceptible to or afflicted withhypercholesterolemia successive therapeutically effective doses of acomposition comprising: a non-absorbable, non-digestible liquid polyolfatty acid polyester having at least 4 fatty acid ester groups, whereinthe polyol is selected from the group consisting of sugars and sugaralcohols containing from 4 to 8 hydroxyl groups and wherein each fattyacid group has from about 8 to about 22 carbon atoms and sufficientanti-anal leakage agent to prevent leakage of said liquid polyesterthrough the anal sphincter.
 22. A method according to claim 21 whereinthe anti-anal leakage agent is a member selected from the groupconsisting of: edible C₁₂ -C₂₄ saturated fatty acids, and their ediblesalts; edible, digestible sources of C₁₂ -C₂₄ saturated fatty acids;edible, non-absorbable, non-digestible solid polyol fatty acidpolyesters having at least 4 fatty acid ester groups, wherein the polyolis selected from the group consisting of sugars and sugar alcoholscontaining from 4 to 8 hydroxyl groups and wherein each fatty acid grouphas from about 8 to about 22 carbon atoms; and edible, non-digestibleesters of alpha-branched chain C₁₀ -C₁₈ fatty acids.
 23. A methodaccording to claim 22 wherein the composition comprises at least about10% by weight of the anti-anal leakage agent.
 24. A method according toclaim 23 wherein the composition comprises at least about 20% by weightof the anti-anal leakage agent. A low calorie fat-containing foodcomposition comprising non-fat ingredients and fat ingredients, whereinfrom about 10% to about 100% of the total fat ingredients comprise:(a) aportion comprising an edible, non-absorbable, non-digestible liquidpolyol fatty acid polyester having at least 4 fatty acid ester groups,wherein the polyol is selected from the group consisting of sugars andsugar alcohols containing from 4 to 8 hydroxyl groups and wherein eachfatty acid group has from about 8 to about 22 carbon atoms; and (b)sufficient anti-anal leakage agent, .Iadd.other than tristearin or C₁₈saturated fatty acid esters of 1,3-propanediol, .Iaddend.to preventleakage of said liquid polyester through the anal sphincter.
 26. Acomposition according to claim 25 wherein the liquid polyol fatty acidpolyester contains no more than about 2 free hydroxyl groups.
 27. Acomposition according to claim 26 wherein the fatty acid ester groupscontain from about 14 to about 18 carbon atoms.
 28. A compositionaccording to claim 27 wherein the polyol is a member selected from thegroup consisting of erythritol, xylitol, sorbitol, glucose and sucrose..[.9. A composition according to claim 28 wherein the polyol issucrose..]. .[.30. A composition according to claim 29 wherein thesucrose fatty acid polyester is a member selected from the groupconsisting of the hexaoleate, heptaoleate and octaoleate of sucrose, andmixtures thereof..].
 31. A composition according to claim 25 wherein theanti-anal leakage agent is a member selected from the group consistingof: edible C₁₂ and higher saturated fatty acids, and their edible salts;edible, digestible sources of C₁₂ and higher saturated fattyacids.Iadd., other than tristearin or C₁₈ saturated fatty acid esters of1,3-propanediol.Iaddend.; edible, non-absorbable, non-digestible solidpolyol fatty acid polyesters having at least 4 fatty acid ester groups,wherein the polyol is selected from the group consisting of sugars andsugar alcohols containing from 4 to 8 hydroxyl groups and wherein eachfatty acid group has from about 8 to about 22 carbon atoms; and edible,non-digestible esters of alpha-branched chain C₁₀ -C₁₈ fatty acids. 32.A composition according to claim 31 wherein the liquid polyester portionof the fat ingredients comprises at least about 10% by weight of theanti-anal leakage agent.
 33. A composition according to claim 32 whereinthe liquid polyester portion of the fat ingredients comprises at leastabout 20% by weight of the anti-anal leakage agent. A compositionaccording to claim 33 wherein the liquid polyester portion of the fatingredients comprises from about 20% to about 50% by weight of theanti-anal leakage agent.
 35. A composition according to claim 31 whereinthe liquid polyester portion of the fat ingredients comprises from about10% to about 50% by weight of an anti-anal leakage agent selected fromthe group consisting of edible C₁₂ -C₂₄ saturated fatty acids and ediblesalts of C₁₂ -C₂₄ fatty acids.
 6. A composition according to claim 31wherein the liquid polyester portion of the fat ingredients comprisesfrom about 10% to about 50% by weight of an anti-anal leakage agentselected from the group consisting of edible, digestible sources of C₁₂-C₂₄ saturated fatty acids, and mixtures thereof.Iadd., other thantristearin or C₁₈ saturated fatty acid esters of1,3-propanediol.Iaddend..
 37. A composition according to claim 36wherein the anti-anal leakage agent is a lower alkyl ester of C₁₂ -C₂₄saturated fatty acids, or mixtures thereof.
 38. A composition accordingto claim 36 wherein the anti-anal leakage agent comprises substantiallysaturated triglyceride esters of C₁₂ -C₂₄ fatty acids, or mixturesthereof.Iadd., other than tristearin.Iaddend..
 39. A compositionaccording to claim 38 wherein the anti-anal leakage agent ishydrogenated palm oil.
 40. A composition according to claim 38 whereinthe anti-anal leakage agent is natural or synthetic cocoa butter.
 41. Acomposition according to claim 38 wherein the anti-anal leakage agent isan edible position-specific triglyceride selected from the groupconsisting of: the 1-stearoyl, 1-palmitoyl, 1-arachidoyl and 1-behenoyl2,3-dioleins; the 2-oleoyl 1,3-distearins, 1,3-dipalmitins,1,3-diarachidins and 1,3-dibehenins; 1-oleoyl distearin; 1-palmitoyldistearin; 1-arachidoyl distearin; and 1-behenoyl distearin; andmixtures thereof.
 42. A composition according to claim 41 wherein theliquid polyester portion of the fat ingredients comprises from about 20%to about 40% by weight of the position-specific triglyceride.
 43. Acomposition according to claim 31 wherein the liquid polyester portionof the fat ingredients comprises from about 20% to about 50% by weightof an anti-anal leakage agent selected from the group consisting ofedible, non-absorbable, non-digestible solid polyol fatty acidpolyesters having at least 4 fatty acid ester groups, wherein the polyolis selected from the group consisting of sugars and sugar alcoholscontaining from 4 to 8 hydroxyl groups and wherein each fatty acid grouphas from about 8 to about 22 carbon atoms.
 44. A composition accordingto claim 43 wherein the anti-anal leakage agent is selected from thegroup consisting of C₁₀ -C₂₂ saturated fatty acid polyol esters.
 45. Apharmaceutical composition in effective unit dosage amounts forinhibiting the absorption of cholesterol without causing an anal leakageeffect, comprising:a. from about 0.1 gram to about 5 grams of an edible,non-absorbable, non-digestible liquid polyol fatty acid polyester havingat least 4 fatty acid ester groups, wherein the polyol is selected fromthe group consisting of sugars and sugar alcohols containing from 4 to 8hydroxyl groups and wherein each fatty acid group has from about 8 toabout 22 carbon atoms; and b. sufficient anti-anal leakage agent toprevent leakage of said liquid polyester through the anal sphincter. 46.A composition according to claim 45 wherein the liquid polyol fatty acidpolyester contains no more than about 2 free hydroxyl groups.
 47. Acomposition according to claim 46 wherein the fatty acid ester groupscontain from about 14 to about 18 carbon atoms.
 48. A compositionaccording to claim 47 wherein the polyol is a member selected from thegroup consisting of erythritol, xylitol, sorbitol, glucose and sucrose.49. A composition according to claim 48 wherein the polyol is sucrose.50. A composition according to claim 49 wherein the sucrose fatty acidpolyester is a member selected from the group consisting of thehexaoleate, heptaoleate and octaoleate of sucrose, and mixtures thereof.51. A composition according to claim 45 wherein the anti-anal leakageagent is a member selected from the group consisting of: edible C₁₂ andhigher saturated fatty acids, and their edible salts; edible, digestiblesources of C₁₂ and higher saturated fatty acids; edible, non-absorbable,non-digestible solid polyol fatty acid polyesters having at least 4fatty acid ester groups, wherein the polyol is selected from the groupconsisting of sugars and sugar alcohols containing from 4 to 8 hydroxylgroups and wherein each fatty acid group has from about 8 to about 22carbon atoms; and edible, non-digestible esters of alpha-branched chainC₁₀ -C₁₈ fatty acids.
 52. A composition according to claim 51 whichcomprises at least about 10% by weight of the anti-anal leakage agent.53. A composition according to claim 51 which comprises at least about20% by weight of the anti-anal leakage agent.
 54. A compositionaccording to claim 51 which comprises from about 20% to about 50% byweight of the anti-anal leakage agent.
 55. A composition according toclaim 51 which comprises from about 10% to about 50% by weight of ananti-anal leakage agent selected from the group consisting of edible C₁₂-C₂₄ saturated fatty acids and edible salts of C₁₂ -C₂₄ fatty acids. 56.A composition according to claim 51 which comprises from about 10% toabout 50% by weight of an anti-anal leakage agent selected from thegroup consisting of edible, digestible sources of C₁₂ -C₂₄ saturatedfatty acids, and mixtures thereof.
 57. A composition according to claim56 wherein the anti-anal leakage agent is a lower alkyl ester of C₁₂-C₂₄ saturated fatty acids, or mixtures thereof.
 58. A compositionaccording to claim 56 wherein the anti-anal leakage agent comprisessubstantially saturated triglyceride esters of C₁₂ -C₂₄ fatty acids, ormixtures thereof.
 59. A composition according to claim 58 wherein theanti-anal leakage agent is hydrogenated palm oil.
 60. A compositionaccording to claim 58 wherein the anti-anal leakage agent is natural orsynthetic cocoa butter.
 61. A composition according to claim 58 whereinthe anti-anal leakage agent is an edible position-specific triglycerideselected from the group consisting of: the 1-stearoyl, 1-palmitoyl,1-arachidoyl and 1-behenoyl 2,3-dioleins; the 2-oleoyl 1,3-distearins,1,3-dipalmitins, 1,3-diarachidins and 1,3-dibehenins; 1-oleoyldistearin; 1-palmitoyl distearin; 1-arachidoyl distearin; and 1-behenoyldistearin; and mixtures thereof.
 62. A composition according to claim 61which comprises from about 20% to about 40% by weight of theposition-specific triglyceride.
 63. A composition according to claim 51which comprises from about 20% to about 50% by weight of an anti-analleakage agent selected from the group consisting of edible,non-absorbable, non-digestible solid polyol fatty acid polyesters havingat least 4 fatty acid ester groups, wherein the polyol is selected fromthe group consisting of sugars and sugar alcohols containing from 4 to 8hydroxyl groups and wherein each fatty acid group has from about 8 toabout 22 carbon atoms.
 64. A composition according to claim 63 whereinthe anti-anal leakage agent is selected from the group consisting of C₁₀-C₂₂ saturated fatty acid polyol esters. .Iadd.65. A compositionaccording to claim 12 wherein said edible sources of saturated fattyacids have an iodine value of from about 9.8 to about
 50. .Iaddend..Iadd.66. A composition according to claim 36 wherein said ediblesources of saturated fatty acids have an iodine value of from about 9.8to about
 50. .Iaddend. .Iadd.67. A composition of matter, comprising:(a)an edible, non-absorbable, non-digestible liquid polyol fatty acidpolyester having at least 4 fatty acid ester groups, wherein the polyolis sucrose and wherein each fatty acid group has from about 8 to about22 carbon atoms; and (b) sufficient anti-anal leakage agent to preventleakage of said liquid polyester through the anal sphincter, wherein theanti-anal leakage agent is a member selected from the group consistingof: edible C₁₂ and higher saturated fatty acids, and their edible salts;edible, digestible sources of C₁₂ and higher saturated fatty acids;edible, non-absorbable, non-digestible solid polyol fatty acidpolyesters having at least 4 fatty acid ester groups, wherein the polyolis selected from the group consisting of sugars and sugar alcoholscontaining from 4 to 8 hydroxyl groups and wherein each fatty acid groupis a saturated fatty acid group having from about 8 to about 22 carbonatoms; and edible, non-digestible esters of alpha-branched chain C₁₀-C₁₈ fatty acids. .Iaddend. .Iadd.68. A composition according to claim67 wherein the sucrose fatty acid polyester is a member selected fromthe group consisting of the hexaoleate, heptaoleate and octaoleate ofsucrose, and mixtures thereof. .Iaddend. .Iadd.69. A compositionaccording to claim 67 which comprises from about 20% to about 50% byweight of an anti-anal leakage agent selected from the group consistingof edible, non-absorbable, non-digestible solid polyol fatty acidpolyesters having at least 4 fatty acid ester groups, wherein the polyolis sucrose and wherein each fatty acid group is a saturated fatty acidgroup having from about 10 to about 22 carbon atoms. .Iaddend. .Iadd.70.A composition according to claim 69 wherein the anti-anal leakage agentis selected from the group consisting of sucrose octastearate, sucroseoctapalmitate, and sucrose heptastearate. .Iaddend. .Iadd.71. A lowcalorie fat-containing food composition comprising non-fat ingredientsand fat ingredients, wherein from about 10% to about 100% of the totalfat ingredients comprise:(a) a portion comprising an edible,non-absorbable, non-digestible liquid polyol fatty acid polyester havingat least 4 fatty acid ester groups, wherein the polyol is sucrose andwherein each fatty acid group has from about 8 to about 22 carbon atoms;and (b) sufficient anti-anal leakage agent to prevent leakage of saidliquid polyester through the anal sphincter. .Iaddend. .Iadd.72. Acomposition according to claim 71 wherein the sucrose fatty acidpolyester is a member selected from the group consisting of thehexaoleate, heptaoleate and octaoleate of sucrose, and mixtures thereof..Iaddend. .Iadd.73. A composition according to claim 71 wherein theliquid polyester portion of the fat ingredients comprises from about 20%to about 50% by weight of an anti-anal leakage agent selected from thegroup consisting of edible, non-absorbable, non-digestible solid polyolfatty acid polyesters having at least 4 fatty acid ester groups, whereinthe polyol is selected from the group consisting of sugars and sugaralcohols containing from 4 to 8 hydroxyl groups and wherein each fattyacid group has from about 8 to about 22 carbon atoms. .Iaddend..Iadd.74. A composition according to claim 73 wherein the anti-analleakage agent is selected from the group consisting of C₁₀ -C₂₂saturated fatty acid polyol esters of sucrose. .Iaddend. .Iadd.75. Acomposition according to claim 74 wherein the anti-anal leakage agent isselected from the group consisting of sucrose octastearate, sucroseoctapalmitate and sucrose heptastearate. .Iaddend. .Iadd.76. Acomposition of matter, comprising fat ingredients and nonfat ingredientsin which at least a portion of the fat ingredients comprise:(a) anedible, non-absorbable, non-digestible liquid polyol fatty acidpolyester having at least 4 fatty acid ester groups, wherein the polyolis selected from the group consisting of sugars and sugar alcoholscontaining from 4 to 8 hydroxyl groups and wherein each fatty acid grouphas from about 8 to about 22 carbon atoms; and (b) sufficient anti-analleakage agent, other than tristearin or C₁₈ saturated fatty acid estersof 1,3-propanediol, to prevent leakage of said liquid polyester throughthe anal sphincter. .Iaddend.